FDA.reportPublic FDA data

NDC 70000-0175-01 - Leader Ibuprofen

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
70000-0175
Requested NDC
70000-0175-01
Package NDCs from labels
70000-0175-1, 70000-0175-2, 70000-0175-3, 70000-0175-5, 70000-0175-4, 70000-0175-7, 70000-0175-6, 70000-0175-8, 70000-0175-9, 70000-0175-01
Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2026-02-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Leader Ibuprofen - Cardinal Health 110, LLC. dba LeaderCardinal Health 110, LLC. dba Leader2026-02-25HUMAN OTC DRUG LABEL
Cardinal Health Ibuprofen Drug FactsRPK Pharmaceuticals, Inc.2022-03-30HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0175-1Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-1Leader Ibuprofen24 in 1 BOTTLETABLET, FILM COATED2414
70000-0175-2Leader Ibuprofen50 in 1 BOTTLETABLET, FILM COATED5014
70000-0175-2Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-3Leader Ibuprofen100 in 1 BOTTLETABLET, FILM COATED10014
70000-0175-3Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-4Leader Ibuprofen250 in 1 BOTTLETABLET, FILM COATED25014
70000-0175-4Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-5Leader Ibuprofen500 in 1 BOTTLETABLET, FILM COATED50014
70000-0175-6Leader Ibuprofen2 in 1 POUCHTABLET, FILM COATED214
70000-0175-7Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-7Leader Ibuprofen120 in 1 BOTTLETABLET, FILM COATED12014
70000-0175-8Leader Ibuprofen200 in 1 BOTTLETABLET, FILM COATED20014
70000-0175-8Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114
70000-0175-9Leader Ibuprofen250 in 1 BOTTLETABLET, FILM COATED25014
70000-0175-9Leader Ibuprofen1 in 1 CARTONTABLET, FILM COATED114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0175LEADER IBUPROFEN (IBUPROFEN) TABLET, FILM COATED [CARDINAL HEALTH 110, LLC. DBA LEADER]12Current NDC, Legacy NDC, 16 package rows20240131_d673266c-3d2b-479f-9b53-cdd1b8651393.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0175-1EA - Each70000-017569331b86-344b-43ea-9142-f19e3f2aa51f12018-05-09
70000-0175-2EA - Each70000-01753ba5d489-6fe5-403a-ad1e-cc378451532a12019-05-02
70000-0175-3EA - Each70000-01752d323018-e0fc-4664-acf2-a496613a8e8e12017-12-14
70000-0175-4EA - Each70000-017564aacbd6-54c7-46f4-b8c0-3160722ad7d512017-12-14
70000-0175-5EA - Each70000-0175c2b24f47-61b9-4519-9d4c-fcfab1369cf012017-12-14
70000-0175-7EA - Each70000-0175d8cec946-a77d-4c4d-91f1-d2a395641fc012018-03-08
70000-0175-8EA - Each70000-0175883670c7-42c4-4862-bc1c-53ce4757609d12022-02-07

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 91 of 190 · 3,790 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DD CreamDD CREAMDERMAdoctor, Inc.08c9a0cf-ee78-483b-e054-00144ff88e882025-10-16WarningsExact identifier
unii: 15FIX9V2JP
IBUPROFEN AND FAMOTIDINEIBUPROFEN AND FAMOTIDINEPHOENIX RX LLC3ff33400-30e8-87fa-e063-6394a90a7f5c2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLC41351cc0-5ec6-2f4d-e063-6294a90a733a2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ciele Filter and ProtectTITANIUM DIOXIDE, ZINC OXIDECiele0309b0ef-baca-b41d-e063-6294a90a49d72025-10-15WarningsExact identifier
unii: 15FIX9V2JP
Defend and Balance TInted Mineral Sunscreen SPF 50SUNSCREENEpicuren Discovery41367f05-59d8-6736-e063-6394a90a5f172025-10-15WarningsExact identifier
unii: 15FIX9V2JP
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICAATOSAFE CO., Ltd41196c2f-8e2e-a54d-e063-6294a90ad8a72025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PEACH MINT WHITENING TOOTHHYDROGEN PEROXIDE, SILICADONG IL PHARMS CO.,LTD41198822-7c8f-ceb2-e063-6394a90a43732025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO ORIGINAL TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD41197bb6-f6f4-c86d-e063-6294a90ad4762025-10-14WarningsExact identifier
unii: ETJ7Z6XBU4
childrens ibuprofenIBUPROFENSafeway6dbf5acc-46a1-4d5b-a9a6-9b77f106d7112025-10-14WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDirect_rx1be33b4f-4987-580f-e063-6294a90a31032025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Skinlycious Multi Protection Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE , ZINC OXIDESkinlycious Pte Ltde0ad02c3-f5ed-4b72-ba96-07d9c489a4ea2025-10-13WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENCoupler LLC410f7320-4caa-8f88-e063-6394a90acf932025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
DENTI BUONGIORNO ORIGINAL TOOTHSILICA, SODIUM MONOFLUOROPHOSPHATEATOSAFE CO., Ltd4114ab09-1115-6b0b-e063-6394a90ab4422025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEATOSAFE CO., Ltd41155922-d7ac-0a7a-e063-6294a90afe482025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO PLAQUE CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATE, TETRASODIUM PYROPHOSPHATEDONG IL PHARMS CO.,LTD41157552-2473-176b-e063-6294a90a9ad02025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEATOSAFE CO., Ltd4115d122-3090-d3e5-e063-6294a90aafb62025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
DENTI BUONGIORNO GUM CARE TOOTHSILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEDONG IL PHARMS CO.,LTD4115b653-63ff-703f-e063-6294a90a652a2025-10-13WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.a85080d7-50b4-461b-9d77-d6fbab971c032025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Vertra S Dorian Kona Gold Signature Face Stick SPF 38TITANIUM DIOXIDEEai-jr 286, Incb6c316c3-661b-6428-e053-2a95a90a1a6b2025-10-10WarningsExact identifier
unii: 15FIX9V2JP
Silicea BelladonnaSILICEA BELLADONNAUriel Pharmacy Inc.a142eb87-c5fb-4138-bc98-e7f1391fe2212025-10-10WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.